Phase 3 Placebo Controlled Study of Nolasiban to Improve Pregnancy Rates in Women Undergoing IVF/ICSI
NCT03081208 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 810
Last updated 2019-12-23
Summary
The primary objective of this study is to confirm the efficacy of a single oral 900mg dose of nolasiban to increase the ongoing clinical pregnancy rate at 10 weeks post embryo transfer (ET) day.
Conditions
Interventions
- DRUG
-
Nolasiban 900mg
Nolasiban dispersible tablets for single oral administration
- DRUG
-
Placebo dispersible tablets for single oral administration
Sponsors & Collaborators
-
ObsEva SA
lead INDUSTRY
Principal Investigators
-
ObsEva SA · Geneva
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 36 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-03-06
- Primary Completion
- 2018-03-21
- Completion
- 2019-02-19
Countries
- Belgium
- Czechia
- Denmark
- Estonia
- Finland
- Germany
- Hungary
- Poland
- Spain
Study Locations
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